A single arm, open-label study to evaluate the efficacy and safety of ABBV-668 in subjects with moderate to severe ulcerative colitis.

Conditions

Ulcerative Colitis

Brief summary

The primary endpoint is the achievement of endoscopic improvement (Mayo ESS of 0 or 1) at Week 8.

Detailed description

The estimands corresponding to the secondary efficacy objectives are: For each binary secondary endpoint specified in Section 3.3: The difference in the proportion of subjects achieving a response in ABBV-668 treatment group in the ITT Population versus in historical placebo group, where subjects will be counted as non-responders after the start of rescue medication (initiation or dose escalation of UC-related corticosteroids)., Achievement of clinical remission per Adapted Mayo score at Week 8., Achievement of clinical response per Adapted Mayo score at Week 8., Achievement of clinical response per Partial Adapted Mayo score at Week 8., Achievement of endoscopic remission at Week 8.

Related papers

No related papers found yet.

Interventions

DRUGABBV-668

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the achievement of endoscopic improvement (Mayo ESS of 0 or 1) at Week 8.	—

Secondary

Measure	Time frame
The estimands corresponding to the secondary efficacy objectives are: For each binary secondary endpoint specified in Section 3.3: The difference in the proportion of subjects achieving a response in ABBV-668 treatment group in the ITT Population versus in historical placebo group, where subjects will be counted as non-responders after the start of rescue medication (initiation or dose escalation of UC-related corticosteroids)., Achievement of clinical remission per Adapted Mayo score at Week 8., Achievement of clinical response per Adapted Mayo score at Week 8., Achievement of clinical response per Partial Adapted Mayo score at Week 8., Achievement of endoscopic remission at Week 8.	—

Measure

Time frame

The estimands corresponding to the secondary efficacy objectives are: For each binary secondary endpoint specified in Section 3.3: The difference in the proportion of subjects achieving a response in ABBV-668 treatment group in the ITT Population versus in historical placebo group, where subjects will be counted as non-responders after the start of rescue medication (initiation or dose escalation of UC-related corticosteroids)., Achievement of clinical remission per Adapted Mayo score at Week 8., Achievement of clinical response per Adapted Mayo score at Week 8., Achievement of clinical response per Partial Adapted Mayo score at Week 8., Achievement of endoscopic remission at Week 8.

—

Countries

Belgium, France, Poland

Outcome results

None listed